GE Medical Systems, LLC: B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,

Hazard

GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.

Details from the source

Reason for recall: GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level. Distribution: Worldwide distribution. Quantity: 826 devices Lot/code info: UDI/DI 00840682147217: Model Number 6160000-001-100174, Serial Numbers: SR422332028WA, SR422332025WA, SR422332026WA, SR422332027WA, SR422332029WA, SR422332030WA, SR422332031WA, SR422332032WA, SR422332049WA, SR422332050WA, SR422332051WA, SR422332052WA, SR422332053WA, SR422332054WA, SR422332055WA, SR422332056WA, SR422332057WA, SR422332061WA, SR422332058WA, SR422332059WA, SR422332060WA, SR422332062WA, SR422332063WA, SR422332064WA, SR422332047WA, SR422332044WA, SR422332045WA, SR422332046WA, SR422332048WA, SR422332033WA, SR422332034WA, SR422332035WA, SR422332036WA, SR422332037WA, SR422332038WA, SR422332039WA, SR422332040WA, SR422332041WA, SR422332042WA, SR422332043WA, SR422332017WA, SR422332018WA, SR422332019WA, SR422332020WA, SR422332021WA, SR422332022WA, SR422332023WA, SR422332024WA, SR422332065WA, SR422332066WA, SR422332067WA, SR422332068WA, SR422332069WA, SR422332070WA, SR422332071WA, SR422332072WA, SR422332081WA, SR422332082WA, SR422332083WA, SR422332084WA, SR422332085WA, SR422332086WA, SR422332087WA, SR422332088WA, SR422332089WA, SR422332090WA, SR422332094WA, SR422332091WA, SR422332092WA, SR422332093WA, SR422332096WA, SR422332095WA, SR422332113WA, SR422332114WA, SR422332115WA, SR422332116WA, SR422332117WA, SR422332118WA, SR422332119WA, SR422332120WA, SR422332121WA, SR422332122WA, SR422332123WA, SR422332127WA, SR422332129WA, SR422332135WA, SR422332136WA, SR422332137WA, SR422332001WA, SR422332002WA, SR422332003WA, SR422332004WA, SR422332005WA, SR422332006WA, SR422332007WA, SR4

UPC codes

00840682147217

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.